Table 1.

Baseline characteristics of included studies

Study	Study design/setting/country	Population
		Inclusion criteria	No of randomized participants (intervention/comparator)	Age (intervention/comparator) (yr), mean±SD	Prostate volume (intervention/comparator) (mL), mean±SD
Ichihara et al. [24] 2015	RCT: open label/multicenter/Japan	Men aged 50 or older with LUTS most likely secondary to BPO	94 (47/47)	75.9 ± 7.5/73.1 ± 8.7	36.5 ± 16.5/31.9 ± 15.7
Kaplan et al. [25] 2020	RCT: double blinded phase IV/multicenter/North America and Europe	Men aged 40 or older who had been receiving 0.4 mg tamsulosin daily for 2 or more months for the treatment of previously diagnosed BPH associated LUTS based on the clinical judgment of the investigator, had symptoms of OAB (8 or more micturitions per day and 2 or more urgency episodes per day), and had a PSA less than 4 ng/mL or 4 to less than 10 ng/mL with a negative biopsy within 2 years	715 (356/359)	64.9 ± 8.4/64.9 ± 9.6	NR
Matsukawa et al. [26] 2019	RCT: open label/single center/Japan	Men aged 50 or older; IPSS ≥ 8; IPSS-quality of life ≥ 3; total OABSS ≥ 3; one or more urinary urgency episodes per week; prostate volume ≥ 25 mL; maximum urinary flow rate < 15 mL/sec at a voided volume of ≥ 100 mL; and residual urine < 150 mL	120 (60/60)	71.5 ± 8.4/72.4 ± 8.2	41.4 ± 16.4/40.1 ± 15.1
Yamanishi et al. [27] 2020	RCT: open label/single center/Japan	Men aged from 50 to 89 years with LUTS (In protocol, patients with BPH)	176 (89/87)	72.4 ± 7.4/72.3 ± 8.0	32.1 ± 13.1/30.5 ± 12.8
Ichihara et al. [24] 2015	Mirabegron (50 mg/day) + tamsulosin (0.4 mg/day)	Tamsulosin (0.2 mg/day)	OABSS	IPSS	8 Weeks (at least 8 weeks tamsulosin 0.2 mg/day)
				Quality of life
				Qmax
Kaplan et al. [25] 2020	Mirabegron (25 mg/day for 4 weeks, and titrated to 50 mg/day for 8 weeks) + tamsulosin (0.4 mg/day)	Placebo + tamsulosin (0.4 mg/day)	No. of micturitions per day	Mean volume voided per micturition	12 Weeks (4 weeks tamsulosin 0.4 mg/day)
				No. of urgency episodes per day (grade 3/4)
				Total urgency and frequency Score
				IPSS
				No. of incontinence episodes per day
				OAB-q symptom bother score
				Patient perception of bladder condition
Matsukawa et al. [26] 2019	Mirabegron (50 mg/day) + silodosin (8 mg/day)	Fesoterodine 4 mg/day + silodosin 8 mg/day	OABSS	Subjective symptoms (IPSS, quality of life)	12 Weeks (12–24 weeks silodosin 8 mg/day)
				Objective findings (bladder volume, detrusor overactivity, Qmax, PVR, detrusor pressure at Qmax, bladder contractility index, bladder outlet obstruction index)
Yamanishi et al. [27] 2020	Mirabegron (50 mg/day) + tadalafil (5 mg/day)	Tadalafil (5 mg/day)	OABSS	OABSS subscore	12 Weeks (at least 8 weeks tadalafil 5 mg/day)
				IPSS
				NIH‐CPSI
				Micturition chart variables (number of voids, number of nighttime voids, number of urgency episodes, number of urgency incontinence episodes)
				Uroflowmetry parameters (voided volume, Qmax, Qave, PVR, bladder voiding efficiency)

IPSS, International Prostate Symptom Score; SD, standard deviation; RCT, randomized controlled trial; LUTS, lower urinary tract symptoms; BPO, benign prostatic obstruction; BPH, benign prostatic hyperplasia; OAB, Overactive Bladder; PSA, prostate specific antigen; NR, not reported.

OABSS, overactive bladder symptom score; IPSS, International Prostate Symptom Score; OAB-q, overactive bladder questionnaire; Qave, average flow rate; PVR, postvoid residual urine volume; Qmax, maximum flow rate; NIH‐CPSI, National Institutes of Health Chronic Prostatitis Symptom Index.